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1 Week Levetiracetam for Brain Cancer
Phase 4
Waitlist Available
Led By Maryam Rahman, MS, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 weeks
Awards & highlights
Study Summary
The purpose of this study is to see if there are any differences in patient reported neurotoxicity between patients who receive Levetiracetam tablets for one week after surgery to remove a brain tumor versus those who receive Levetiracetam tablets for six weeks after surgery. Specifically, we will see if one group has less side effects than the other, and whether or not one group has more seizures than the other.
Eligible Conditions
- Brain Cancer
- Seizures
- Brain Tumor
- Brain Metastases
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Neurotoxicity Scale Scores
Side effects data
From 2006 Phase 4 trial • 251 Patients • NCT0016065430%
Somnolence
14%
Dizziness
6%
Sedation
6%
Fatigue
6%
Headache
6%
Nausea
2%
Convulsion
1%
Grand mal convulsion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Levetiracetam
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 1 Week LevetiracetamExperimental Treatment1 Intervention
Levetiracetam taken by mouth at a daily dose of 1000 mg for one week.
Group II: 6 Week LevetiracetamActive Control1 Intervention
Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levetiracetam
2017
Completed Phase 4
~3990
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,345 Previous Clinical Trials
718,236 Total Patients Enrolled
Maryam Rahman, MS, MDPrincipal InvestigatorUniversity of Florida
Frequently Asked Questions
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